RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma. PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.

Condition	Treatment or Intervention	Phase
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma	Drug: dexamethasone  Drug: isotretinoin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen.

PROTOCOL OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed multiple myeloma
• Elevated monoclonal protein in serum and/or urine

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: Prior palliative radiotherapy allowed
• Surgery: At least 3 weeks since prior major surgery

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,000/mm3*; Platelet count at least 75,000/mm3* *Unless secondary to multiple myeloma involvement of the bone marrow
• Hepatic: Bilirubin less than 1.5 mg/dL; Transaminase less than 2 times normal
• Renal: Creatinine less than 2.0 mg/dL; No overt renal insufficiency
• Cardiovascular: No congestive heart failure; No myocardial infarction within the past 6 months; No significant arrhythmia or poorly controlled hypertension
• Pulmonary: No severe pulmonary disease
• Other: Triglycerides normal; No other severe medical illness; No active peptic ulcer disease; No brittle insulin-dependent diabetes; No severe depression or other psychiatric illness; No active infection; No history of severe ethanol or drug abuse; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

New Jersey
      Community Medical Center, Toms River,  New Jersey,  08755,  United States
      Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly,  New Jersey,  08060,  United States
      Hunterdon Regional Cancer Center, Flemington,  New Jersey,  08822,  United States
      Kimball Medical Center, Lakewood,  New Jersey,  08701,  United States
      Riverview Medical Center - Booker Cancer Center, Red Bank,  New Jersey,  07701,  United States
      South Jersey Regional Cancer Center, Millville,  New Jersey,  08332,  United States
      St. Francis Medical Center, Trenton,  New Jersey,  08629,  United States
Pennsylvania
      Bon Secours-Holy Family Health System, Altoona,  Pennsylvania,  16602,  United States
      Conemaugh Memorial Hospital, Johnstown,  Pennsylvania,  15905,  United States
      Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      North Penn Hospital, Lansdale,  Pennsylvania,  19446-1200,  United States
      Paoli Memorial Hospital, Paoli,  Pennsylvania,  19301-1792,  United States
      Pinnacle Health Hospitals, Harrisburg,  Pennsylvania,  17105-8700,  United States
      Pottstown Memorial Regional Cancer Center, Pottstown,  Pennsylvania,  19464,  United States
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
      Saint Mary Regional Center, Langhorne,  Pennsylvania,  19047,  United States
      Southern Chester County Medical Center, West Grove,  Pennsylvania,  19390,  United States

Study chairs or principal investigators

Russell J. Schilder,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000068772; FCCC-95043; NCI-G01-1985
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00021359
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08